Global QMS Director: Compliance, Audits & Quality

BioSpace; Waltham (MA); On-site; USD 196,000 - 230,000; Full time

Job summary

Dyne Therapeutics is seeking a Director of Quality Management Systems based in Waltham, MA. The role leads global QMS design, supplier quality, audits, and product complaint management, ensuring an inspection-ready, scalable system aligned with ICH Q10, FDA CFRs, and international standards.

The position partners with cross-functional teams to embed quality as a strategic driver, balancing risk, compliance, and business needs while scaling toward commercial operations.

Qualifications

• Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred.
• 10+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred)
• Demonstrated leadership experience with direct ownership of QMS and quality systems
• Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements
• Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems

Responsibilities

• Leads QMS strategy, compliance & inspection readiness for commercial operations
• Manages risk-based internal audits and CAPA processes across functions
• Oversees supplier quality program and supplier qualification
• Manages end-to-end product complaint management lifecycle for commercial distribution
• Defines quality metrics and KPIs; drives continuous improvement
• Leads eQMS implementation, validation, and governance

Skills

Quality leadership

Regulatory knowledge

Cross-functional leadership

GxP experience

Strategic thinking

Operational execution

Risk management

Communication

Education

Bachelor’s degree in science or Quality Systems Management

Tools

Veeva eQMS

MasterControl

Learning Management Systems

Job description

Dyne Therapeutics is seeking a Director of Quality Management Systems based in Waltham, MA. The role leads global QMS design, supplier quality, audits, and product complaint management, ensuring an inspection-ready, scalable system aligned with ICH Q10, FDA CFRs, and international standards.

The position partners with cross-functional teams to embed quality as a strategic driver, balancing risk, compliance, and business needs while scaling toward commercial operations.